[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3827-3828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0319]


Guidance for Industry and Food and Drug Administration Staff on 
Dear Health Care Provider Letters: Improving Communication of Important 
Safety Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry and FDA staff entitled ``Dear 
Health Care Provider Letters: Improving Communication of Important 
Safety Information.'' This guidance offers specific recommendations to 
industry on the content and format of Dear Health Care Provider (DHCP) 
letters. These letters are sent by manufacturers or distributors to 
health care providers to communicate an important drug warning, a 
change in prescribing information, or a correction of misinformation in 
prescription drug promotional labeling or advertising. This guidance 
provides recommendations on when to use a DHCP letter, the types of 
information to include in the DHCP letter, how to organize the 
information so that it is communicated effectively to health care 
providers, and formatting techniques to make the information more 
accessible. This guidance finalizes the draft guidance issued in 
November 2010.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office of 
Communication, Outreach and Development (HFM-40), Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that

[[Page 3828]]

office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori A. Bickel, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993, 301-796-
0210; or Stephen Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Dear Health Care Provider Letters: Improving 
Communication of Important Safety Information.'' This document offers 
specific guidance to industry and FDA staff on the content and format 
of DHCP letters. These letters are sent by manufacturers or 
distributors to health care providers to communicate an important drug 
warning, a change in prescribing information, or a correction of 
misinformation in prescription drug promotional labeling or 
advertising. This guidance gives specific instruction on what should 
and should not be included in DHCP letters. To date, some DHCP letters 
have been too long, have contained promotional material, or otherwise 
have not met the goals set forth in the applicable regulation (21 CFR 
200.5). In some cases, health care providers have not been aware of 
important new information, and have been unable to communicate it to 
patients, because the letters' content and length have made it 
difficult to find the relevant information. In addition, letters have 
sometimes been sent for the wrong reasons.
    In addition to content and format recommendations for each type of 
DHCP letter, the guidance also includes advice on consulting with FDA 
to develop a DHCP letter, when to send a letter, what type of letter to 
send, and conducting an assessment of the letter's impact.
    In the Federal Register of November 12, 2010 (75 FR 69449), FDA 
announced the availability of a draft guidance for industry and FDA 
staff entitled ``Dear Health Care Provider Letters: Improving 
Communication of Important Safety Information.'' The notice gave 
interested persons an opportunity to comment by January 11, 2011. The 
Agency received several comments from health care providers, firms, and 
other groups. We have carefully considered the comments and, where 
appropriate, have made corrections, added information, or clarified 
information in the guidance in response to the comments or on our own 
initiative. This guidance finalizes the draft guidance issued in 
November 2010.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on ``Dear Health Care Provider Letters: 
Improving Communication of Important Safety Information.'' It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control number 0910-0754.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.regulations.gov.

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01305 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P